EQRx chairman Alexis Borisy (L) and CEO Melanie Nallichieri

EQRx adds ar­mor to its dis­count check­point in­hibitor sub­mis­sion, nail­ing sur­vival mark in key study

The rules say you can’t dis­rupt any mar­ket un­less you are, in fact, a part of that mar­ket — and self-styled drug pric­ing dis­rup­tor EQRx is one step clos­er to do­ing just that.

A com­bi­na­tion of EQRx and CStone’s PD-(L)1 drug sug­e­mal­imab and chemother­a­py sig­nif­i­cant­ly pro­longed pa­tients’ lives over place­bo in pa­tients with new­ly di­ag­nosed stage IV non-small cell lung can­cer, ac­cord­ing to up­dat­ed da­ta from the Phase III GEM­STONE-302 study un­veiled Tues­day evening.

The topline win on this key sec­ondary end­point backs up da­ta the part­ners re­leased back in May with the sug­e­mal­imab-chemo com­bo sig­nif­i­cant­ly cut­ting pa­tients’ risk of dis­ease pro­gres­sion or death.

These fuller re­sults — hard da­ta on the OS end­point are still un­der lock and key — should add ar­mor to EQRx and CStone’s push to get sug­e­mal­imab across the fin­ish line as a proof-of-con­cept for the for­mer’s grow­ing pipeline of dis­count­ed drugs.

Vince Miller

“Price re­mains a bar­ri­er to ac­cess­ing in­no­v­a­tive ther­a­pies for many peo­ple with lung can­cer around the world, de­spite the avail­abil­i­ty of mul­ti­ple an­ti-PD-(L)1 ther­a­pies,” said Vince Miller, EQRx’s physi­cian-in-chief, in a state­ment. “We look for­ward to en­gag­ing with glob­al reg­u­la­to­ry au­thor­i­ties with the aim of de­liv­er­ing a low­er-cost treat­ment op­tion to pa­tients up­on ap­proval.”

EQRx is run­ning a sec­ond, all-Chi­nese Phase III study for sug­e­mal­imab as con­sol­i­da­tion ther­a­py in a sub­set of these pa­tients. The drug­mak­er read out re­sults at last year’s ES­MO show­ing a sug­e­mal­imab-chemo com­bo post­ed a me­di­an pro­gres­sion-free sur­vival of 9 months com­pared with 5.8 months for pa­tients giv­en place­bo (p=0.0026).

A self-styled drug pric­ing dis­rup­tor, EQRx has earned bio­phar­ma’s ear with a game plan to sig­nif­i­cant­ly un­der­cut com­peti­tor pric­ing by tar­get­ing “fi­nan­cial­ly tox­ic” drug mar­kets with­out any mean­ing­ful price com­pe­ti­tion. Im­muno-on­col­o­gy rep­re­sents a nat­ur­al first ef­fort with sev­en ap­proved PD-(L)1 drugs on the US mar­ket and no dis­count­ed op­tion avail­able.

Sug­e­mal­imab, a Chi­nese-born can­di­date, could rep­re­sent EQRx’s first re­al shot at chal­leng­ing some ma­jor play­ers in this space, but con­vinc­ing the FDA the drug adds some­thing mean­ing­ful to pa­tients in a packed field will be a chal­lenge in and of it­self. On Tues­day, EQRx high­light­ed that the sug­e­mal­imab-chemo com­bo showed “clin­i­cal ben­e­fit” across PD(L)1 ex­press­ing sub­types — po­ten­tial­ly a point of dif­fer­en­ti­a­tion, but the full da­ta aren’t avail­able.

As EQRx looks to dis­rupt these drug mar­kets, Big Phar­ma has tak­en note to a de­gree. Eli Lil­ly, which is hop­ing to bring its own PD-(L)1 drug to the US mar­ket in sin­til­imab, an­nounced back in Sep­tem­ber it would take the dis­count­ing road if its se­cures FDA ap­proval along­side part­ner In­novent.

At the time, EQRx praised that de­ci­sion with CEO Melanie Nal­licheri say­ing, “I ap­plaud them and that’s fan­tas­tic.” But it rais­es a ques­tion: If fi­nan­cial tox­i­c­i­ty in some of these mar­kets is so ob­vi­ous and the dis­count­ing strat­e­gy is vi­able, then why haven’t oth­er drug­mak­ers al­ready done it?

EQRx thinks that bring­ing a wave of drugs to ap­proval could help its busi­ness op­er­ate at scale, chal­leng­ing Big Phar­ma in ar­eas it wouldn’t think to dis­count. But do­ing so re­quires cut­ting costs across the board, both at clin­i­cal and pre­clin­i­cal scale as well as in mar­ket­ing. The biotech cov­ered one side of that equa­tion back in June, ink­ing a re­search col­lab­o­ra­tion with buzzy AI start­up Ex­sci­en­tia, which boasts its abil­i­ty to sig­nif­i­cant­ly cut drug dis­cov­ery costs through its deep learn­ing plat­form.

Mean­while EQRx has leaned on clin­i­cal tri­als run abroad to cut costs down even more while build­ing a “buy­er’s club” of pri­vate in­sur­ers, all in an ef­fort to make the eco­nom­ics work. Will they? That’s still left to be seen.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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